Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06471673 | A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer | PHASE1 | RECRUITING | 18 | — | — | May 29, 2024 | Oct 30, 2025 | Aug 26, 2024 | 1 | United States |
Total number of AEs
To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Safety Laboratory Parameters
To evaluate the safety of BC1 as assessed by: o Electrocardiograms (ECG) with measurement of the QT interval
To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Physical Examination Findings and Abnormal Vital Signs
| Arm | Type | Description |
|---|---|---|
| Phase 1, Part 1 Monotherapy Phase | EXPERIMENTAL | Subject 1, Q2w for 4 doses Subject 2, Q2w for 4 doses Subject 3, Q2w for 4 doses Treatment is administered every 2 weeks for a total of 4 doses. Initially, safety will be assessed on these 3 subjects. DLTs are defined as CTCAE Grade 3 or 4 adverse events that are suspected to be possibly related to study treatment. If 1 of 3 Phase 1 subjects experience a DLT, that dose cohort will be expanded to another 3 patients before the combinational phase begins. A total of 3-6 subjects will be assessed for safety. |
| Phase 1, Part 2 Combination Phase | EXPERIMENTAL | 3 subjects will be treated every 3 weeks with the Bria-OTS regimen with a CPI (tislelizumab) in the Part 2 combination phase. The Bria-OTS regimen consists of cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell line inoculation. On the same day as the cell inoculation, subjects will receive peginterferon alpha-2a. Subjects will also receive the CPI (tislelizumab) on the same day of the cell inoculation according to approved dosing. Treatment is administered every 3 weeks in combination with the Bria-OTS regimen and CPI (tislelizumab). |
| Phase 2 Expansion Cohort | EXPERIMENTAL | Once 3 patients have been safely treated with the Bria-OTS regimen and CPI (tislelizumab) for 2 cycles, Phase 2 will enroll an expansion cohort, consisting of up to an additional 9 subjects (for a total of 12 treated with the Bria-OTS regimen and CPI). The Bria-OTS regimen consists of cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell line inoculation. On the same day as the cell inoculation, subjects will receive peginterferon alpha-2a. Subjects will also receive the CPI (tislelizumab) on the same day of the cell inoculation according to approved dosing. Treatment is administered every 3 weeks in combination with the Bria-OTS regimen and CPI (tislelizumab). |
| Name | Type | Description |
|---|---|---|
| BC1 cell line | BIOLOGICAL | BC1 cell line is a different experimental, HER-2 positive, allogeneic, whole cell BC cell lines designed to secrete GM-CSF in situ and augment dendritic cell activity. Similar to the SV-BR-1-GM cell line (NCT03328026, IND 10312), the BC cell line is derived from the BC parent cell line, SV-BR-1, which expresses multiple tumor associated antigens (TAAs) |
| Bria-OTS regimen and CPI (tislelizumab) | BIOLOGICAL | Biological: BC1 * BC1 inoculation intradermally at 4 sites Drug: Low dose cyclophosphamide * Pretreatment with low dose cyclophosphamide 2-3 days prior to BC1 inoculation Drug: Interferon * Subjects will receive low dose peginterferon alpha-2a on the same day as cell inoculation. Drug: Tislelizumab * CPI treatment will also be given on the same day as cell inoculation. |
| Bria-OTS regimen and CPI (tislelizumab) expansion cohort | BIOLOGICAL | Biological: BC1 * BC1 inoculation intradermally at 4 sites Drug: Low dose cyclophosphamide * Pretreatment with low dose cyclophosphamide 2-3 days prior to BC1 inoculation Drug: Interferon * Subjects will receive low dose peginterferon alpha-2a on the same day as cell inoculation. Drug: Tislelizumab * CPI treatment will also be given on the same day as cell inoculation. |
Key Inclusion Criteria: 1. Histological confirmed recurrent metastatic breast cancer which has failed prior therapy defined as: 1. Human epidermal growth factor 2 (EGFR2, HER2) positive tumors must have failed therapy with at least 2 anti-HER2 agents 2. HER2 negative and either ER or PR p...